KHO — Fluorometer, For Clinical Use Class I
FDA product code KHO covers "Fluorometer, For Clinical Use", a Class I medical device regulated under 21 CFR 862.2560. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KHO
- Device Class
- Class I
- Regulation Number
- 862.2560
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K112161 | radiometer medical aps | AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, | January 20, 2012 |
| K973547 | biosite incorporated | TRIAGE STATMETER | January 13, 1998 |
| K971103 | tosoh medics | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM | June 27, 1997 |
| K962919 | johnson and johnson clinical diagnostics | VITROS IMMUNODIAGNOSTIC SYSTEM | October 18, 1996 |
| K952719 | biocircuits | BIOCIRCUITS IOS (IN-OFFICE SYSTEM) | November 22, 1995 |
| K950415 | isolab | FLUOROSCAN NEONATAL | September 5, 1995 |
| K935047 | wallac | AUTO DELFIA | May 23, 1994 |
| K930689 | bio-chem laboratory systems | AUTOBEAD THYROID UPTAKE | November 10, 1993 |
| K926131 | pb diagnostic systems | OPUS MAGNUM ANALYZER | June 7, 1993 |
| K923021 | tosoh | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | July 21, 1992 |
| K920888 | dynatech laboratories | MICROLITE MICROTITER PLATE LUMINOMETER ML2200 | March 19, 1992 |
| K913130 | baxter healthcare | STRATUS IINTELLECT IMMUNOASSAY SYSTEM | September 27, 1991 |
| K901674 | tosoh | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | May 2, 1990 |
| K895240 | pharmacia | DELFIA PLATE FLUOROMETER 1232 | October 4, 1989 |
| K894159 | pb diagnostic systems | OPUS IMMUNOASSAY SYSTEM | August 3, 1989 |
| K890908 | baxter healthcare | STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES | March 24, 1989 |
| K872803 | cyberfluor | CYBERFLUOR 615 IMMUNOANALYZER | September 2, 1987 |
| K871550 | perkin-elmer | PFI-20 POLARIZING FLUORIMETER | July 1, 1987 |
| K860309 | helena laboratories | HEMAFLUOR REAGENT KIT | July 14, 1986 |
| K851984 | lkb instruments | LKB-WALLAC 1230 ARCUS FLUOROMETER | May 24, 1985 |